NAT-19/GPX
Research type
Research Study
Full title
Double-blind, randomised, placebo-controlled, dose-finding phase IIb trial to evaluate the efficacy, safety, and tolerability of a 12-week-treatment with Naronapride in adult participants with at least moderate idiopathic or diabetic gastroparesis
IRAS ID
1005261
Contact name
Tanju Nacak
Contact email
Sponsor organisation
Dr. Falk Pharma GmbH
Eudract number
2021-002254-86
Clinicaltrials.gov Identifier
Research summary
Background, goal
This study is part of the development program of a new medication for Gastroparesis, an illness where the stomach does not empty in a normal way but with delay; which can cause symptoms such as nausea, vomiting, abdominal pain, bloating and feeling overly full after meals. So far, there is no medication for treatment of this illness available on the European market - only surgical procedures and medications to ameliorate the symptoms.
The name of the medication under investigation in this study is Naronapride. Naronapride has previously been tested in healthy persons and for other illnesses of the digestive system. Aim of the present study is to find out, if the medication is effective for treatment of two forms of Gastroparesis - ideopathic (this means "whithout known cause") and diabetic (i.e. as secondary complication of diabetes) gastroparesis. Moreover, potential undesirable effects of the treatment shall be recorded. Patients, participating in the study will be treated with tablets containing one of three different doses of Naronapride or with Placebo (tablets identical in appearance and composition to the others but without Naronapride). Afterwards, it will be evaluated wich dosage has the most favourable efficacy-to-safety-profile.Participation, procedures
Adult women and men, who have been diagnosed with ideopathic or diabetic gastroparesis and fulfill the participation criteria (e.g. certain other medications should not be taken and certain other diseases or conditions should not be present or have occured in the past, so as to not jeopardize the safety of the participants or confound the data raised).
The study takes place in the EU as well as at 7 NHS study sites in England, Scotland and Wales. Study duration per person takes up to 20 weeks (including a treatment period of 12 weeks and a 4 weeks follow-up phase). The main tests performed are physical examinations, breath tests, endoscopies, ECGs, questionaires and blood tests.REC name
London - Central Research Ethics Committee
REC reference
22/LO/0767
Date of REC Opinion
17 Apr 2023
REC opinion
Further Information Favourable Opinion